Sr Associate, Manufacturing (Technical Authoring/Deviation Investigations))

About the role

Support the manufacturing team and provide technical expertise to draft and revise documents such as Standard Operating Procedures (SOPs), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.

Responsibilities

• Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols & reports for manufacturing team.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents.
• Liaise with manufacturing team and other cross-functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and / or troubleshooting projects.
• Support manufacturing team in reducing document turnaround times.
• Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.
• Develop protocols for Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.
• Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA, complaints, and change control records.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

Requirements

• High school/GED + 4 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Associates + 2 years years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Bachelors + 6 months years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
• Master's - Educational Background in Science and/or Engineering.
• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and demonstrated background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Dynamic skills and usage of photographs, drawings, diagrams, animation, and charts that increase users understanding.
• Experience supporting deviations, investigations, CAPAs and change controls.
• A fact-based problem solver with strong troubleshooting and problem-solving skills.
• Pro-active with the ability to prioritize work to meet benchmarks.
• Good documentation and communication skills.

Qualifications

• Basic Qualifications: High school/GED + 4 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.

Skills

• Strong technical writing skills.
• Experience with GMP regulations.
• Excellent communication and collaboration skills.
• Problem-solving and troubleshooting abilities.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models where possible.

Pay

Commensurate with experience.

Schedule

Full time.